GENETIC INFORMATION
NONDISCRIMINATION
ACT OF 2008:
WHAT EMPLOYERS SHOULD KNOW
TO AVOID LIABILITY UNDER THE MORE
SUBTLE PROVISIONS OF THE ACT
BY Erin Flynn, ESQ.
The Genetic Information
Nondiscrimination Act of 2008 (GINA)
was signed into law by George W.
Bush on May 21, 2008. The law, which
protects against discrimination by
insurers and employers based on
an individual’s genetic information,
came about in response to growing
concerns that the protections in
the law weren’t keeping up with the
advances in the laboratory.
14
Nevada Lawyer
June 2011
Fantastic advances are
being made in connection
with disease prevention and
management through the
use of genetic information
to design more effective
drug therapy with fewer side
effects and to tailor medical
treatment more specifically to
an individual. However, people
are concerned about what
will happen if an employer or
insurer finds out a person has a
genetic predisposition towards
certain diseases. GINA allows
individuals to take advantage
of these scientific advances
without fearing that they will
lose their jobs or insurance
coverage if they do.
There are two separate
titles to GINA. Title I deals with
discrimination in the context of
health insurance. Title II (to which this article
is limited) deals with discrimination in the
context of employment practices. The Equal
Employment Opportunity Commission issued
final regulations implementing the provisions
of Title II effective January 10, 2011.
GINA’s Subtler Side
Many employers have heard about GINA
for some time and have been aware of Title II’s
general prohibition against discrimination, in
the employment setting, based on an individual’s
genetic information. Satisfied they know better
than to consider genetic information when
making hiring, firing or compensation decisions,
such employers may believe they have nothing to
worry about now that the final GINA regulations
have gone into effect.
What employers should be aware of is that
GINA reaches far beyond discrimination – it also
prohibits employers from requesting, requiring or
purchasing genetic information on an individual
or family member. Again, many employers will be
satisfied with their employment practice because
they do not ask employees for “that kind” of
information. However, what most employers may
not be aware of is that the definition of “request”
is not limited to actively soliciting genetic
information from employees, but is actually broad
enough to include information found during an
internet search or gleaned from actively listening
to lunch room or so-called “water cooler” talk.
It can also include asking about an employee’s
sick mom or about an employee’s pregnancy if
the conversation or follow-up questions are too
probing. These subtler violations of GINA are
what employers need to be concerned with.
Thankfully, there are numerous
exceptions to help employers avoid certain
GINA violations, but knowledge of the law
is important in order to understand what
is required for the exceptions to apply or,
more importantly, to prevent employers from
obtaining genetic information in cases where
there is no exception.
Finally, employers need to be aware of their
obligation with respect to maintaining genetic
information once they receive it. Employers
must also post certain notices regarding
the provisions of GINA and how to file
a complaint in connection with GINA
violations.
committees, together with employers and employing
offices, are collectively referred to as “covered
entities.”2 It is important that employers realize
a “covered entity” under GINA is different than a
covered entity under the Health Insurance Portability
and Accountability Act of 1996 (HIPAA).3 Many
people are familiar with the term “covered entity” and
believe it generally refers to health care providers,
which it does under HIPAA, but covered entity has a
different meaning under GINA. Thus, when reading
the additional prohibitions below, the first question
to ask is whether a business is a covered entity under
GINA. If it is a covered entity, GINA will generally
apply to it and its employment practices.
GINA Basics:
To Whom Does
GINA Apply and
What Does
She Prohibit?
GINA prohibits employers with 15
or more employees from discriminating
“against an individual on the basis of the
genetic information of the individual in regard
to hiring, discharge, compensation, terms,
conditions or privileges of employment.”1 This
same prohibition applies conceptually, though
in slightly different forms, due to their differing
relationship to employees, to employment
agencies, labor organizations and joint labormanagement committees.
Under GINA, employment agencies, labor
organizations and joint labor-management
June 2011
Nevada Lawyer
15
GENETIC INFORMATION
NONDISCRIMINATION
ACT OF 2008
continued from page 15
In addition to the general prohibition against
discrimination based on genetic information, GINA
also prohibits a covered entity from requesting,
requiring or purchasing genetic information of an
individual or family member of the individual...4 For
reference in this article, these prohibitions will be
collectively referred to as the Acquisition Prohibition.
As mentioned above, the Acquisition Prohibition
is where most employers are likely to get into
trouble, because the definition of request is so broad.
“Request” includes:
• Conducting an internet search on an
individual in a way that is likely to result in a
covered entity obtaining genetic information;
• Actively listening to third-party conversations;
or
• Searching an individual’s personal effects for
the purposes of obtaining genetic information;
and
• Making requests for information about an
individual’s current health status in a way that
is likely to result in a covered entity obtaining
genetic information.
Genetic Information
Clearly, a key element in a GINA analysis,
whether it involves alleged discrimination or
violation of the Acquisition Prohibition, is whether
the information used or obtained is “genetic
information.” If the information in question is not
genetic information, there is not a GINA violation in
connection with it. Genetic information includes:
• Information about the genetic tests of an
individual or of the individual’s family
members;
• Manifestation of disease or disorder in the
individual’s family members (medical history);
• An individual’s receipt or request for genetic
services or participation by the individual or a
family member in clinical research that includes
genetic services; or
• Genetic information about a fetus carried by
an individual or a fetus carried by her family
member or any embryo held by the individual
or the individual’s family member using
assisted reproductive technology.5
There are numerous exceptions to the Acquisition
Prohibition, but the exceptions have fairly particular
requirements that must be met in order to prevent
GINA liability. These exceptions, which are described
in more detail below, include:
• Inadvertent requests for genetic information;
• Acquisition of genetic information in
connection with a voluntary wellness program;
• Requests for medical information in order to
comply with the Family and Medical Leave Act
16
Nevada Lawyer
June 2011
of 1993 or other similar state or
local family leave laws;
• Commercially or publicly
available information;
• Monitoring the biological effects
of toxic substances in the work
place; and
• DNA analysis for law
enforcement purposes.
Inadvertent Requests
Inadvertent requests include
situations where an employer
acquires genetic information from
an employee in response to a lawful
request for medical information,
such as in connection with a request
for accommodations under the
Americans with Disabilities Act.
When an employer requests such
medical information it must direct
the employee not to include genetic
information in the employee’s
response. However, there are
times when an employee provides
genetic information in spite of
such a directive. In these cases, the
acquisition of genetic information
will be considered inadvertent so long
as the directive contains certain safe
harbor language such as:
GINA prohibits employers and other
entities covered by GINA Title II
from requesting or requiring genetic
information of an individual or family
member of the individual, except as
specifically allowed by this law. To
comply with this law, we are asking
that you not provide any genetic
information when responding to
this request for medical information.
“Genetic information,” as defined
by GINA, includes an individual’s
family medical history, the results of
an individual’s or family member’s
genetic tests, the fact that an
individual or an individual’s family
member sought or received genetic
services, and genetic information of
a fetus carried by an individual or
an individual’s family member or an
embryo lawfully held by an individual
or family member receiving assistive
reproductive services.6
continued on page 19
June 2011
Nevada Lawyer
17
GENETIC INFORMATION
NONDISCRIMINATION
ACT OF 2008
continued from page 17
If a covered entity fails to use the safe harbor
language when making its request for medical
information, it can still show that the acquisition
of genetic information was inadvertent, if it can
show the request was not “likely to result in the
covered entity receiving genetic information.”7
The inadvertent request exception can also
apply when an employer overhears a conversation
between or among employees or when the
employer asks an “ordinary question of concern.”
However, if the employer follows up with questions
that are probing in nature, such as whether other
family members have the condition being discussed
or whether the employee has also been tested if
the subject is a family member, this exception
does not apply, because “the covered entity should
know these questions are likely to result in the
acquisition of genetic information.”8
other state or local leave laws, there will not be a
GINA violation in connection with the request for
such information.10
Commercially and
Publicly Available
Acquisition of genetic information from
documents that are commercially and publicly
available for review or purchase is not a violation
of the Acquisition Prohibition provided that the
documents were not on databases with restricted
or limited access or where the covered entity
is likely to acquire genetic information such as
chat rooms of social network pages that focus on
genetic issues.11
Monitoring Biological Effects
of Toxic Substances
A covered entity will not commit a violation of
the Acquisition Prohibition if it acquires genetic
continued on page 20
Voluntary Wellness
Programs
Wellness programs are a great way to
promote healthy living and reduce costs
in connection with the provision of health
insurance to employees, but in order for
a covered entity to avoid violating the
Acquisition Prohibition in connection
with wellness programs, provision of
genetic information in connection with
participation in the program must be
voluntary. “Voluntary” requires that not
only is provision of genetic information
not required, but that a participant
cannot be penalized for failure to provide
it. Financial inducements offered in
connection with the program cannot be
tied to provision of genetic information
and if financial inducements are offered,
an explanation using basic language easy
for the participant to understand must
make that fact clear.9
FMLA
If a covered entity requests a family
medical history to comply with the
certification provisions of the FMLA or
June 2011
Nevada Lawyer
19
GENETIC INFORMATION
NONDISCRIMINATION
ACT OF 2008
continued from page 19
information in connection with monitoring
biological effects of toxic substances in the
workplace so long as the covered entity provides
notice of the monitoring and keeps the individual
apprised of the results of the monitoring. This
exception further requires that the monitoring
be required by law and conducted in accordance
therewith, or with knowing, voluntary and written
authorization of the subject. The authorization
must meet certain requirements as well.12
DNA Analysis for Law
Enforcement
It is not a violation of the Acquisition
Prohibition if an employer uses genetic information
in connection with DNA analysis as a forensic lab
or in connection with identification of remains.13
Requirements for Maintaining
Genetic Information and
Limitation on Disclosure of
Genetic Information
While the foregoing exceptions set forth
when the request for, requirement of or purchase
of genetic information is not a violation of the
Acquisition Prohibition, what a covered entity does
with genetic information it has legally obtained can
be a violation of other provisions of Title II.
A covered entity must keep genetic
information in medical files that are separate from
personnel files and treat the information as a
confidential medical record.14 Genetic information
that a covered entity acquires through oral
communication is not required to be reduced to
writing but may only be disclosed under the same
circumstances as written genetic information.15
Written genetic information may only be
disclosed as follows:
• To the employee or family
member about whom it
pertains;
• To an occupational or other
health researcher, subject
to certain federal research
requirements;
• In response to a court order
so long as the information
disclosed is specifically
covered by the order;
• To government officials
investigating a GINA
violation;
• In support of an employee’s
compliance with
certification requirements
of FMLA or other state leave
laws; or • To a federal, state or local
health agency in connection
with the manifestation of
contagious disease that
presents an imminent
hazard of death or lifethreatening illness.16
In connection with
disclosures pursuant to a court
order or to a health agency, the
subject of the disclosure must
be notified of the disclosure.
20
Nevada Lawyer
June 2011
Doesn’t HIPAA Cover
This Kind of Thing?
Title II does not apply to genetic
information that is considered
protected health information and
subject to the regulations of HIPAA.17
If an entity is covered by HIPAA, it
must follow the HIPAA regulations
with respect to genetic information.
If an entity is a GINA-covered entity,
the GINA provisions govern how it
acquires, maintains and discloses
genetic information. Penalties for GINA
Violations
Penalties for GINA violations
include compensatory and punitive
damages, as well as attorneys’ fees
and certain expert fees. Injunctive
relief is also available, which can
include reinstatement and hiring,
back pay and other equitable
remedies.18
Erin Flynn is a shareholder
with the firm of Lionel Sawyer
& Collins. Her practice areas
include health care law and
transactional Law. Flynn received
her J.D. degree from California
Western School of Law. She is a member of
the American Health Lawyers Association.
You may contact Flynn at (702) 383-8956 or
via e-mail at [email protected]
1 29 C.F.R. § 1635.4 (a).
2 29 C.F.R. § 1635.2 (b).
3 The interplay of HIPAA and GINA is discussed
more fully below.
4 29 C.F.R. § 1635.8 (a).
5 29 C.F.R. § 1635.3 (c).
6 29 C.F.R. § 1635.8 (b)(1)(i)(B).
7 29 C.F.R. § 1635.8 (b)(1)(i)(C).
8 29 C.F.R. § 1635.8 (b)(1)(ii)(A)-(B).
9 29 C.F.R § 1635.8 (b)(2)(i)-(ii).
10 29 C.F.R § 1635.8 (b)(3).
11 29 C.F.R § 1635.8 (b)(4).
12 29 C.F.R § 1635.8 (b)(5).
13 29 C.F.R § 1635.8 (b)(6). This exception is
specific to employers.
14 29 C.F.R §1635.9 (a)(1).
15 29 C.F.R. § 1635.9 (a)(3).
16 29 C.F.R. § 1635.9 (b)(1)-(6).
17 29 C.F.R. § 1635.11 (d).
18 29 C.F.R § 1635.10 (b).
SH
June 2011
Nevada Lawyer
21